2-Year Results of Paclitaxel-Coated Balloons for Long Femoropopliteal Artery Disease

• Published in: JACC. Cardiovascular interventions Vol. 10; no. 7; pp. 728 - 734
• Main Authors: Micari, Antonio, MD, PhD, Nerla, Roberto, MD, Vadalà, Giuseppe, MD, Castriota, Fausto, MD, Grattoni, Chiara, MD, Liso, Armando, MD, Russo, Paolo, MD, Pantaleo, Paolo, MD, Roscitano, Giuseppe, MD, Cremonesi, Alberto, MD
• Format: Journal Article
• Language: English
• Published: Elsevier Inc 01.04.2017
• Subjects: 24 months; Cardiovascular; drug-eluting balloons; long lesions; superficial femoral artery disease; drug-eluting balloons; 24 months; target lesion revascularization; CI; PCB; SFA; percutaneous transluminal angioplasty; TransAtlantic Inter-Society Consensus; superficial femoral artery disease; paclitaxel-coated balloon; superficial femoral artery; long lesions; confidence interval; TASC; TLR; PTA
• ISSN: 1936-8798; 1876-7605
• DOI: 10.1016/j.jcin.2017.01.028

Abstract Objectives The aim of this study was to appraise 2-year outcomes after percutaneous transluminal angioplasty of long femoropopliteal artery disease using paclitaxel-coated balloons (PCBs). Background Percutaneous transluminal angioplasty with PCBs for TransAtlantic Inter-Society Consensus types C and D femoropopliteal artery disease has provided favorable results ≤12 months but no prospective studies performed longer term follow-up assessment. Methods Consecutive patients with Rutherford class 2 to 4 disease due to femoropopliteal lesions >15 cm long were prospectively enrolled in a multicenter study. The primary study endpoint was primary patency (i.e., freedom from the combined endpoint of clinically driven target lesion revascularization and >50% restenosis in the treated lesion as appraised by a duplex ultrasound peak systolic velocity ratio of >2.4) at 24 months. Secondary endpoints included major adverse events (the composite of death, target limb amputation, thrombosis at the target lesion, or clinically driven nontarget lesion revascularization), changes in Rutherford class, and quality of life ≤24 months post-procedure. Results A total of 105 patients (age 68 ± 9 years; 81.9% men) successfully treated with PCBs were included (treated lesion length was 251 ± 71 mm; 49.5% total occlusions). The 24-month follow-up data were available in 98 patients; they showed a primary patency rate of 70.4%, with major adverse events occurred in 10 patients (10.2%, 5 non–procedure-related deaths) and persistently significant clinical benefits in Rutherford class (51% of asymptomatic patients at 24 months). Conclusions PCBs benefits on primary patency and target vessel revascularization satisfactorily extend over 24 months in patients undergoing percutaneous transluminal angioplasty for symptomatic femoropopliteal disease.